Ftc Backs Challenge To Glaxo

The Federal Trade Commission has sided with Apotex Inc., a Canadian drug company with U.S. headquarters in Weston, in its attempt to bring a generic form of the antidepressant Paxil to consumers.

Apotex is battling GlaxoSmithKline PLC in federal court over whether certain patents protect the drug from generic competition. The drug brought Glaxo $1.8 billion in U.S. sales last year.

In a Philadelphia action, the generic company contends that two Glaxo patents were listed improperly with the Food and Drug Administration and should be declared invalid. Another suit, over another patent, is scheduled for trial in Chicago next week.

In a friend of the court brief, the FTC supports Apotex's motion in the Philadelphia case for an order requiring Glaxo to ask the FDA to de-list the two patents. The agency's brief notes that competition is stifled by improper patent listings, and it describes benefits to consumers when "artificial barriers" to lower-cost generics exist.

"We're very glad the FTC is taking a position on the issue. We are trying to break down those barriers and get this product to market," Tammy McIntire, the president of Apotex U.S. operations, said in a telephone interview from Puerto Rico where she is attending a generic drug conference. "We will continue to fight the battle."

If Apotex were to prevail in court and be the first to market a generic Paxil, the company would be granted a six-month exclusivity for the drug and perhaps generate hundreds of millions of dollars in the first year.